Preparation of quality file and variation dossiers
- Veterinary medicinal products: part II and I.C. (in accordance with the Notice To Applicants (NTA) format for EU)
- Pharmaceuticals for human use: Quality Overall Summary 2.3 and Module 3 (in accordance with the Common Technical Document (CTD) format for US, EU and Japan.
Expertise for part II (vet) of European Dossiers
Quality (Pharmaceutical) Expert report (including tabular format summary)
Technical and regulatory assistance for the development of new medicinal products and generics
- Development programmes and set-up of study plans in accordance with regulatory requirements
- Establishment of specifications for the finished products, for raw materials not described in Pharmacopoeia (internal monograph) and for packaging.
Assessment of existing dossiers and drug master files (Active Substance Master File)
Verification of admissibility of studies to the Agencies
